In response to the COVID-19 outbreak, FDA has postponed most foreign inspections through April. Inspections outside the U.S. deemed
FDA based the decision on the State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees; CDC travel recommendations; access restrictions being imposed on foreign visitors by certain countries; guidance from the Office of Personnel Management; and the importance of the health and safety of its employees. “Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” the FDA statement said, adding, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
As an interim measure, FDA is employing additional tools to ensure the safety of products imported to the U.S., including denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition, and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. FDA exercised this authority when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.
FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The agency also has the ability through our risk-based import screening tool (PREDICT) to focus its examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. FDA also is keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. The agency can refuse admission of products that fail sample testing or may violate other applicable legal requirements.
As this remains a dynamic situation, the agency will continue to assess and calibrate its approach as needed to help advance federal response efforts in the fight against this outbreak.